510(k) · Cleared
ClearedAG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Andon Health Co, Ltd. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Feb 16, 2017 as substantially equivalent to K110017 (Andon Medical Co., Ltd., 2012) after a 430-day review. Its family tree reaches back 4 generations to 2003.
- Decided
- Feb 16, 2017
- Review
- 430 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K024194 (2003). No later device cites it as a predicate yet.
- Root · 4 generations backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
- 3 generations backK073030 AG-605 Blood Glucose Monitoring SystemAndon Health Co, Ltd. · 2008
- 2 generations backK093262 AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose…Andon Medical Co., Ltd. · 2010
- 1 generation backK110017 AG-608N Blood Glucose Monitoring SystemAndon Medical Co., Ltd. · 2012
- This deviceK153561 AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood…Andon Health Co, Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems | Lifescan, Inc. | 2003 | 5 |
| −3 | K073030 | AG-605 Blood Glucose Monitoring System | Andon Health Co, Ltd. | 2008 | — |
| −2 | K093262 | AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose Monitoring… | Andon Medical Co., Ltd. | 2010 | — |
| −1 | K110017 | AG-608N Blood Glucose Monitoring System | Andon Medical Co., Ltd. | 2012 | — |
| 0 (this device) | K153561 | AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose… | Andon Health Co, Ltd. | 2017 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NBW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NBW device
- #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110017 | AG-608N Blood Glucose Monitoring SystemSummary page 5…device information Manufacturer: Andon Medical Co., Ltd. Device: AG-608N Single Blood Glucose Monitoring System 510(k) number: K110017 5-1 AG-607 Blood Glucose M onitoring System FDA 510(k) Files… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 3 other devices also cite its predicate K110017.
How does its category compare?
All NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · NBW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
The AG-607 blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The AG-607 blood glucose monitoring system is intended to be used by a Single person and should not be shared. The AG-607 blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with…
Read the full statement (316 words)
The AG-607 blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The AG-607 blood glucose monitoring system is intended to be used by a Single person and should not be shared.
The AG-607 blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AG-607 blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative Site Testing (AST) should be done only during steady-state times (when glucose levels is not changing rapidly).
The EGS-2003 test strips are for use with the AG-607 blood glucose meter to quantitatively measure glucose(sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh.
The AG-607Multi blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The AG-607Multi blood glucose monitoring system is intended for testing outside the body(in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as and aid to monitor the effectiveness of diabetes control program. The system is only used with single-use auto-disabling lancing device.
The AG-607Multi blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative Site Testing (AST) should be done only during steady-state times (when glucose levels is not changing rapidly).
The EGS-2003 test strips are for use with the AG-607Multi blood glucose meter to quantitatively measure glucose(sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153561: AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153561
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026